Hydrocortisone (hydrocortisone 20 mg) Dailymed

8246901/0815OS Rx only

Description

Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.

The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below.

Hydrocortisone tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate.

Actions

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

Indications And Usage

Hydrocortisone tablets are indicated in the following conditions.

• 1. Endocrine Disorders
•  Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)
•  Congenital adrenal hyperplasia
•  Nonsuppurative thyroiditis
•  Hypercalcemia associated with cancer
• 2. Rheumatic Disorders
•  As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
•  Psoriatic arthritis
•  Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
•  Ankylosing spondylitis
•  Acute and subacute bursitis
•  Acute nonspecific tenosynovitis
•  Acute gouty arthritis
•  Post-traumatic osteoarthritis
•  Synovitis of osteoarthritis
•  Epicondylitis
• 3. Collagen Disease
•  During an exacerbation or as maintenance therapy in selected cases of:
•  Systemic lupus erythematosus
•  Systemic dermatomyositis (polymyositis)
•  Acute rheumatic carditis
• 4. Dermatologic Diseases
•  Pemphigus
•  Bullous dermatitis herpetiformis
•  Severe erythema multiforme (Stevens-Johnson syndrome)
•  Exfoliative dermatitis
•  Mycosis fungoides
•  Severe psoriasis
•  Severe seborrheic dermatitis
• 5. Allergic States
•  Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
•  Seasonal or perennial allergic rhinitis
•  Serum sickness
•  Bronchial asthma
•  Contact dermatitis
•  Atopic dermatitis
•  Drug hypersensitivity reactions
• 6. Ophthalmic Diseases
•  Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
•  Allergic conjunctivitis
•  Keratitis
•  Allergic corneal marginal ulcers
•  Herpes zoster ophthalmicus
•  Iritis and iridocyclitis
•  Chorioretinitis
•  Anterior segment inflammation
•  Diffuse posterior uveitis and choroiditis
•  Optic neuritis
•  Sympathetic ophthalmia
• 7. Respiratory Diseases
•  Symptomatic sarcoidosis
•  Loeffler's syndrome not manageable by other means
•  Berylliosis
•  Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
•  Aspiration pneumonitis
• 8. Hematologic Disorders
•  Idiopathic thrombocytopenic purpura in adults
•  Secondary thrombocytopenia in adults
•  Acquired (autoimmune) hemolytic anemia
•  Erythroblastopenia (RBC anemia)
•  Congenital (erythroid) hypoplastic anemia
• 9. Neoplastic Diseases
•  For palliative management of:
•  Leukemias and lymphomas in adults
•  Acute leukemia of childhood
• 10. Edematous States
•  To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
• 11. Gastrointestinal Diseases
•  To tide the patient over a critical period of the disease in:
•  Ulcerative colitis
•  Regional enteritis
• 12. Nervous System
•  Acute exacerbations of multiple sclerosis
• 13. Miscellaneous
•  Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
•  Trichinosis with neurologic or myocardial involvement

Contraindications

Systemic fungal infections and known hypersensitivity to components

Warnings

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

Corticosteroids may mask some signs of infection, and new infections may appear during their use.

There may be decreased resistance and inability to localize infection when corticosteroids are used.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Usage in Pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response.

The use of hydrocortisone tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered.

Precautions

General Precautions

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (see DOSAGE AND ADMINISTRATION ).

Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Information for the Patient

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Adverse Reactions

Fluid and Electrolyte Disturbances

    Sodium retention    Fluid retention    Congestive heart failure in susceptible patients    Potassium loss    Hypokalemic alkalosis    Hypertension

Musculoskeletal

    Muscle weakness    Steroid myopathy    Loss of muscle mass    Osteoporosis    Vertebral compression fractures    Aseptic necrosis of femoral and humeral heads    Pathologic fracture of long bones

Gastrointestinal

    Peptic ulcer with possible perforation and hemorrhage    Pancreatitis    Abdominal distention    Ulcerative esophagitis

Dermatologic

    Impaired wound healing    Thin fragile skin    Petechiae and ecchymoses    Facial erythema    Increased sweating    May suppress reactions to skin tests

Neurological

    Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment    Convulsions    Vertigo    Headache

Endocrine

    Development of Cushingoid state    Suppression of growth in children    Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness    Menstrual irregularities    Decreased carbohydrate tolerance    Manifestations of latent diabetes mellitus    Increased requirements for insulin or oral hypoglycemic agents in diabetics

Ophthalmic

    Posterior subcapsular cataracts    Increased intraocular pressure    Glaucoma    Exophthalmos

Metabolic

    Negative nitrogen balance due to protein catabolism

Dosage And Administration

The initial dosage of hydrocortisone tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, hydrocortisone should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of hydrocortisone for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.

Multiple Sclerosis

In treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (20 mg of hydrocortisone is equivalent to 5 mg of prednisolone).

How Supplied

Hydrocortisone Tablets, USP 5 mg are white, scored, round tablets debossed “3578” on one side and debossed “V” on the reverse side; and are supplied as follows:

Unit dose packages of 30 (5 x 6) NDC 68084-789-25

Hydrocortisone Tablets, USP 20 mg are white, scored, round tablets debossed “3580” on one side and debossed “V” on the reverse side; and are supplied as follows:

Unit dose packages of 30 (5 x 6) NDC 68084-930-25

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if buler is torn or broken.

Packaging Information

American Health Packaging unit dose bulers (see How Supplied section) contain drug product from Qualitest Pharmaceuticals as follows:

(5 mg / 30 UD) NDC 68084-789-25 packaged from NDC 0603-3899(20 mg / 30 UD) NDC 68084-930-25 packaged from NDC 0603-3901

Distributed by: American Health Packaging Columbus, OH 43217

8246901/0815OS

Principal Display Panel 5 Mg

 

NDC 68084-789-25

HYDROCORTISONE TABLETS, USP

5 mg

30 Tablets (5 x 6)

Each Tablet Contains: Hydrocortisone, USP……………………… 5 mg

Usual Dosage: See package insert for fullprescribing information

WARNING: This potent drug must be used onlyunder the direct supervision of a physician.

Store at 20° to 25°C (68° to 77°F); excursionspermitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if buler istorn or broken.

Rx Only

The drug product contained in this package is from NDC # 0603-3899, Qualitest Pharmaceuticals.

Distributed by:American Health PackagingColumbus, Ohio 43217

078925Rev. 08/2015OS

Principal Display Panel 20 Mg

 

NDC 68084-930-25

HYDROCORTISONE TABLETS, USP

20 mg

30 Tablets (5 x 6)

Each Tablet Contains: Hydrocortisone, USP……………………… 20 mg

Usual Dosage: See package insert for fullprescribing information

WARNING: This potent drug must be used onlyunder the direct supervision of a physician.

Store at 20° to 25°C (68° to 77°F); excursionspermitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if buler istorn or broken.

Rx Only

The drug product contained in this package is from NDC # 0603-3901, Qualitest Pharmaceuticals.

Distributed by:American Health PackagingColumbus, Ohio 43217

093025Rev. 08/2015OS